An observational study in Gastroparesis and Esophageal Cancer, sponsored by Institute for Clinical and Experimental Medicine. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Institute for Clinical and Experimental Medicine · Observational
This is a retrospective study assessing the effectiveness of endoscopic pyloromyotomy in patients suffering from gastroparesis and/or symptoms of delayed gastric emptying after esophagectomy with gastric pull-through. Several, mainly European, centres which perform G-POEM on a routine basis will be asked to participate. The main reason to assess the effectiveness of G-POEM in this specific subgroup of patients is the fact this specific subgroup of patients is often being excluded from trials assessing efficacy and safety of G-POEM.
The participating centres will be asked to report appropriate patients among those who have undergone G-POEM since 2015 till December 2023. Patients fulfilling inclusion and not having exclusion criteria will be included into the analysis; the minimum follow-up is set to 6 months after G-POEM. The main outcome is the symptomatic response at 6, 12 and 24 months (measured by GCSI score). Other endpoints will be change in other symptoms not covered by GCSI, change in gastric emptying rate and safety of the procedure.
For each enrolled patient a case report form (CRF) will be filled in and delivered to the leading centre via an online database or in other forms if preferred by the respective centres. The leading centre will be responsible for data collection and analysis.
307 studies on the registry are indexed under Gastroparesis; 68 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 77 observational studies indexed under Gastroparesis.
Browse Gastroparesis studies →Institute for Clinical and Experimental Medicine is the lead sponsor of 60 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients who underwent G-POEM after esophagectomy with a gastric pull-through in any of the participating centers since January 2015 till December 2023.
Exclusion Criteria:
GCSI score
Gastroparesis Cardinal Symptom Index questionnaire: The score ranges from 0 to 5 for each symptom (9 questions) and these are averaged into subscores and into a total score (also ranging from 0 to 5). Higher scores indicate more severe symptoms.
Time frame: At baseline and 3, 6, 12, 24, 36 months after G-POEM
Gastric emptying by scintigraphy
Gastric scintigraphy protocol endorsed by both American Neurogastroenterology and Motility Society and American Nuclear Medicine Society will be used to assess gastric emptying with a standard 200 kcal, 2% fat egg-substitute test meal. Gamma camera images will be obtained immediately after meal ingestion and then at 1, 2, 3 and 4 hours. Diagnostic criterion for delayed gastric emptying is defined as the percentage of gastric retention \>60% at 2 h or ≥ 10% at 4 h or both. Half-time (T1/2) emptying time will also be calculated. At least 72 hours before gastric emptying test, narcotics and other medications that can interfere with gastric emptying will be discontinued.
Time frame: At baseline and 3, 6, 12, 24, 36 months after G-POEM
Gastric emptying by breath test
Gastric emptying assessed using 13C breath test with octanoic acid. This measurement is an alternative to the measurement of gastric emptying by scintigraphy. The choice depends on the practice in a particular center.
Time frame: At baseline and 3, 6, 12, 24, 36 months after G-POEM
Pyloric distensibility
Pyloric distensibility measured by impedance planimetry (EndoFLIP device)
Time frame: At baseline and 3, 6, 12, 24, 36 months after G-POEM
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Institute for Clinical and Experimental Medicine